An Approach to Aggregate Safety Reporting of Drug and Device Constituent Parts of Combination Products

Time

Tue, Jun 16 9:00AM
T 38

Title

An Approach to Aggregate Safety Reporting of Drug and Device Constituent Parts of Combination Products

Abstract Summary

This poster will be present on Tuesday, June 16 in Session #1C at 2:56 - 3:01 pm in the Exhibit Hall Poster Area (Hall A entrance)

A variety of regulatory submission formats for Medical Device Reporting from seven regulatory bodies were reviewed. Formats were evaluated for clarity and ease of use. An aggregate safety report annex for device complaints was developed. The pilot Annex was submitted with a Combination Product PSUR.

Poster Presenter

Xaymara Roman
RN,
Aggregate Safety Manager,
AbbVie Inc
United States